Container for storing a parameter settings report for an implantable medical device and a method for using the container

ABSTRACT

A method for protecting a parameter settings report for an implanted medical device is disclosed. The method comprises the steps of receiving a parameter settings report for an implanted medical device from a medical facility; folding the parameter settings report is folded into a compact size; opening a container, wherein that container includes a base piece and a cover piece with the base piece including a plurality of side walls, an open top side defined by the plurality of sidewalls, and an internal storage volume; placing the folded parameter settings report into the container; and closing the container.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/779,160, filed Mar. 3, 2006, which application is incorporated herein by reference in its entirety.

TECHNICAL FIELD

The present invention relates generally to containers and storage methods.

BACKGROUND

Implantable medical devices (IMD) are commonly used to treat patients having abnormal or irregular cardiac rates or rhythms. A typical IMD is a pacemaker. A pacemaker is used to monitor a patient's heart rate, and is designed to increase the patient's heart rate with a series or pattern of electrical impulses if the patient's heart rate falls below a predetermined level. Another type of MD is an implantable cardioverter defibrillator (ICD). An ICD monitors a patient's heart rate and is designed to slow a patient's heart rate with one or more electrical shocks if the patient's heart rate exceeds a predetermined level.

When an IMD is implanted in a patient, a relatively large number of parameters are set to optimize performance of the IMD with respect to the patient. The parameter settings are typically provided to the patient on a Parameter Settings Report. A Parameter Settings Report may also include hemodynamic data for the patient. Example parameters and hemodynamic data can be found at U.S. Pat. No. 6,792,310 and U.S. Pat. No. 7,003,349 which are hereby incorporated by reference in their entireties. Further parameters and hemodynamic data can be found at US Patent Application Publication No. US 2004/0220636 A1, which is also hereby incorporated by reference in its entirety. After initial implantation, patients typically periodically visit their physicians to verify the operating condition and performance of their IMD. With each visit, parameter settings for the IMD may be modified and updated Parameter Settings Reports can be provided to the patients.

In the event of a heart-related medical emergency involving a person having an IMD, the Parameter Settings Report for the IMD is a valuable tool for use in diagnosing and treating the patient. For this reason, a patient having an IMD is encouraged to have his or her Parameter Setting Reports readily accessible at all times. Frequently, the patients place the Parameter Settings Reports in their wallets or purses. This is problematic because the Parameter Settings Reports are difficult to locate and may become smeared, blurred or otherwise damaged thereby rendering the reports difficult to read.

SUMMARY

One aspect of the present disclosure relates to a container for storing a Parameter Settings Report corresponding to an IMD. In certain embodiments, the container is small enough to easily be kept in a patient's pocket. In certain embodiments, the container has a plastic construction that prevents the Parameter Settings Report held within the container from being bent, crushed or otherwise damaged. In still other embodiments, the container has a hinged or removable lid for allowing the Parameter Settings Report to be easily accessed within the container. In still further embodiments, the container can have exterior indicia for allowing a third party to readily recognize that important medical information is held within the container.

Another aspect of the present disclosure relates to a method for protecting a parameter settings report for an implanted medical device. A parameter settings report for an implanted medical device is received from a medical facility. The parameter settings report is folded into a compact size. A container is opened, wherein that container includes a base piece and a cover piece with the base piece including a plurality of side walls, an open top side defined by the plurality of sidewalls, and an internal storage volume. The folded parameter settings report is placed into the container and the container is closed.

A variety of additional inventive aspects will be set forth in the description that follows. The inventive aspects can relate to individual features and to combinations of features. It is to be understood that both the forgoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the broad inventive concepts upon which the embodiments disclosed herein are based.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a further understanding of the present invention and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present invention and together with the description serve to further explain the principles of the invention. Other aspects of the present invention and many of the attendant advantages of the present invention will be readily appreciated as the present invention becomes better understood by reference to the following Detailed Description when considered in connection with the accompanying drawings, and wherein:

FIG. 1 is a front, left, top perspective view of a container in accordance with the principles of the present disclosure for storing and protecting a Parameter Settings Report of an IMD;

FIG. 2 is a left, side view of the container of FIG. 1;

FIG. 3 is a front view of the container of FIG. 1;

FIG. 4 is a right, side view of the container of FIG. 1;

FIG. 5 is a top view of the container of FIG. 1;

FIG. 6 is a rear view of the container of FIG. 1; and

FIG. 7 is a bottom view of the container of FIG. 1.

DETAILED DESCRIPTION

Reference will now be made in detail to the exemplary aspects of the present invention that are illustrated in the accompanying drawings. Whenever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

FIG. 1 shows a container 20 having features that are examples of inventive aspects in accordance with the principles of the present disclosure. The container 20 can also be referred to as a case, a box, a cartridge, a package, or other like terms. The container 20 is preferably sized to hold a Parameter Settings Report of an IMD. The container 20 is also preferably sized to easily fit within a patient's pocket or purse to allow the patient to carry the Parameter Settings Report with them at all times.

Referring still to FIG. 1, the container 20 includes a base piece 22 defining an internal storage volume 24 sized for holding a Parameter Settings Report. A top side 25 of the base piece 22 is open. The container 20 also includes a cover piece 26 that is used to close the open top side 25 of the base piece 22. As depicted in FIG. 1, the cover piece 26 is connected to the base piece 22 by a living hinge 28. In one example embodiment, the container 20 is a molded plastic part having sufficient rigidity to prevent a Parameter Settings Report positioned within the container from being unintentionally folded, bent or crushed.

Referring to FIGS. 1, 2 and 5, the base piece 22 of the container 20 includes a generally rectangular bottom wall 30 that defines a major bottom side of the container 20. The base piece 22 also includes a sidewall structure 32 that projects upwardly from the bottom wall 30. A curved/contoured transition 33 is provided between the bottom wall 30 and the sidewall structure 32.

The sidewall structure 32 defines a generally rectangular perimeter of the container 20. It also cooperates with the bottom wall 30 to define the rectangular internal storage volume 24. The sidewall structure 32 includes opposing sidewalls 38, 40 that define a width W of the container 20, and opposing sidewalls 42, 44 that extend between the sidewalls 38, 40 and define a length L of the container 20. The sidewalls 38, 40 are connected to the sidewalls 42, 44 by rounded corners.

The open top side 25 of the base piece 22 is defined by the inner surface of a lip 34 that projects upwardly from the sidewall structure 32. An exterior shoulder 36 is defined at the junction between the bottom of the lip 34 and the top of the sidewall structure 32.

Referring to FIGS. 1, 2, 4, 5, 6 and 7, the cover piece 26 is also rectangular and is sized to fit over the lip 34 of the base piece 22 to enclose the internal storage volume 24 of the container 20. The cover piece 26 includes a top wall 45 that defines a major top side of the container 20 when the container 20 is closed. The top wall 45 of the cover piece 26 opposes and is generally parallel to the bottom wall 30 of the base piece 22 when the container 20 is closed.

The cover piece 26 includes a rim 46 that extends around the perimeter of the cover piece 26. A curved/contoured transition 47 is provided between the top wall 45 and the rim 46. The cover piece 26 also includes an internal shoulder 48 that also extends around the perimeter of the cover piece 26 and is recessed relative to the rim 46. When the cover piece 26 is closed on the base piece 22, the rim 46 seats upon the exterior shoulder 36 of the base piece 22, and the internal shoulder 48 abuts against the lip 34 of the base piece 22.

The cover piece 26 also includes two recesses 50 sized to receive corresponding tabs 52 provided on the base piece 22. When the cover piece 26 is closed on the base piece 22, the tabs 52 snap within the recesses 50 to retain the cover piece 26 in the closed position. The base piece 22 also includes an exterior finger recess 54 that provides clearance for allowing a user to place their finger beneath a portion of the rim 46 to facilitate opening the cover piece 26.

It is preferred for the container 20 to include exterior indicia or markings to allow a third party (e.g., a paramedic, a nurse or a treating physician) to readily recognize the contents of the container 20. For example, the indicia can be written on the container, placed on a sticker on the container, or molded into the exterior surface of the container. Example text that may be provided on the container include “Medical Information”, “Pacemaker Parameter Settings Report Enclosed”, “ICD Parameter Settings Report Enclosed” or like descriptions. Other information can also be provided on the exterior of the container. For example, the exterior indicia of the container may list the patient's name, phone number and address. The indicia may also include the treating physician's name (i.e., the physician that installed the IMD and generated the Parameter Settings Report) as well as the treating physician's phone number and address.

It is preferred for the container 20 to be sized to receive a conventional Parameter Settings Report while still being sufficiently small to allow the patient to readily carry the container with them at all times. An example Parameter Settings Report may include six paper panels each about 4½ inches wide and 6 inches long. The panels are typically connected by perforated edges. By folding the panels at the perforated edges and then further folding the panels, the report can be compacted to a reasonable size capable of being carried by a patient.

It is preferred for the container 20 to be reasonably small. In one embodiment, the length L of the container is less than 4 inches, the width W of the container is less than 3 inches, and a thickness of the container (the distance between the outer surfaces of the top and bottom walls when the container is closed) is less than 0.75 inches. In the preferred embodiment, the container has a length of about 3.3 inches, a width of about 2.5 inches, and a thickness of about 0.625 inches. In alternative embodiments, the container may have a tapered thickness that tapers along the width of the container so that one side of the container is thicker than the other side of the container.

In use, a patient will visit his or her attending physician and will receive a Parameter Settings Report for their implanted medical device. Upon receiving the report, the patient will fold the report and place the report in the container 20. Once in the container, the report is protected from being further folded, bent, smeared, torn, or otherwise damaged. The report is also protected from getting wet. The patient then carries the container 20 with them at all times. In the event the patient has a heart-related medical emergency, the indicia on the container allows treating personnel to quickly find and read the Parameter Settings Report. This assists in providing a timely diagnosis and treatment for the patient.

It will be appreciated that containers in accordance with principles of the present disclosure can be distributed by physicians, hospitals, and/or IMD manufacturers as part of a program for encouraging patients to carry their Parameter Settings Reports with them at all times.

Various modifications and alterations of this invention will become apparent to those skilled in the art without departing from the scope and spirit of this invention, and it should be understood that this invention is not to be unduly limited to the illustrative embodiments set forth herein. 

1. A method for protecting a parameter settings report for an implanted medical device comprising the steps of: receiving a parameter settings report for an implanted medical device from a medical facility; folding the parameter settings report into a compact size; opening a container, wherein the container includes a base piece and a cover piece, wherein the base piece has a plurality of sidewalls, an open top side defined by the plurality of sidewalls, and an internal storage volume; placing the folded parameter settings report into the internal storage volume of the container; and closing the container.
 2. A method for protecting a parameter settings report for an implanted medical device as claimed in claim 1, wherein the cover piece is connected to the base piece by a living hinge.
 3. A method for protecting a parameter settings report for an implanted medical device as claimed in claim 1, wherein the cover piece is selectively removable from the base piece.
 4. A method for protecting a parameter settings report for an implanted medical device as claimed in claim 1, wherein the container is molded plastic.
 5. A method for protecting a parameter settings report for an implanted medical device as claimed in claim 4, wherein the molded plastic is of sufficient rigidity to prevent the parameter settings report from being folded when the parameter settings report is inside the internal storage volume of the container.
 6. A method for protecting a parameter settings report for an implanted medical device as claimed in claim 1, wherein the open top side of the base piece of the container is defined by an inner surface of a lip that projects from the plurality of sidewalls.
 7. A method for protecting a parameter settings report for an implanted medical device as claimed in claim 6, wherein the cover piece includes a rim that extends around the perimeter of the cover piece and encloses the lip of the base piece.
 8. A method for protecting a parameter settings report for an implanted medical device as claimed in claim 1, wherein the cover piece includes at least one recess sized to receive a corresponding tab on the base piece.
 9. A method for protecting a parameter settings report for an implanted medical device as claimed in claim 1, wherein the base piece includes an exterior finger recess to facilitate opening the cover piece.
 10. A method for protecting a parameter settings report for an implanted medical device as claimed in claim 1, wherein the container includes exterior indicia for identification.
 11. A method for protecting a parameter settings report for an implanted medical device as claimed in claim 10, wherein the exterior indicia are on a sticker affixed to the container.
 12. A method for protecting a parameter settings report for an implanted medical device as claimed in claim 10, wherein the exterior indicia are molded into an exterior surface of the container.
 13. A method for protecting a parameter settings report for an implanted medical device as claimed in claim 10, wherein the exterior indicia include patient identification.
 14. A method for protecting a parameter settings report for an implanted medical device as claimed in claim 10, wherein the exterior indicia include physician identification.
 15. A method for protecting a parameter settings report for an implanted medical device as claimed in claim 10, wherein the exterior indicia include identification of contents within the container.
 16. A method for protecting a parameter settings report for an implanted medical device as claimed in claim 1, wherein the container is rectangular.
 17. A method for protecting a parameter settings report for an implanted medical device as claimed in claim 16, wherein the length of the container is less than 4 inches, the width is less than 3 inches, and the thickness is less than 0.75 inches.
 18. A method for protecting a parameter settings report for an implanted medical device as claimed in claim 1, wherein the medical facility is a hospital.
 19. A method for protecting a parameter settings report for an implanted medical device as claimed in claim 1, wherein the containers are distributed by a member selected from the group consisting of physicians, hospitals, and implanted medical device manufacturers.
 20. A method for a medical facility to encourage a patient to carry a parameter settings report for an implanted medical device comprising: providing the patient with a pocket sized container for holding and protecting a folded parameters setting report, wherein the container includes a base piece and a cover piece, wherein the base piece has a plurality of sidewalls and an open top side defined by the plurality of sidewalls. 